Anchoring system for a medical article

ABSTRACT

An anchoring system includes a simply-structured device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suturing. The anchoring system desirably includes a retainer and an anchor pad. The retainer is sized and configured to accept and retain a section of a catheter within the anchoring system and desirably includes a pair of posts and a clip. The posts are sized and configured to releasably accept holes formed in the catheter or catheter fitting. The clip is sized and configured to releasably accept a portion of the catheter. The anchor pad secures the retainer to a patient&#39;s skin.

RELATED CASES

[0001] This application claims priority under 35 U.S.C. § 119(e) ofProvisional Application No. 60/______, filed Aug. 18, 1998, thisprovisional application was converted from application Ser. No.09/136,271 by petition filed on Aug. 12, 1999.

BACKGROUND OF THE INVENTION

[0002] 2. Field on the Invention

[0003] The present invention relates in general to an anchoring systemfor securing a medical article to a patient and, in particular, to ananchoring system for securing a catheter or other elongated medicalarticle to a patient to inhibit movement or migration of the catheter ormedical article relative to the patient.

[0004] 2. Description of Related Art

[0005] It is very common in the treatment of patients to utilizecatheters to introduce fluids and medications directly into the patientor to withdraw fluids from the patient. For example, one catheterutilized to introduce fluids into a patient is a midline catheter.

[0006] In many cases, the catheter remains in place for several days orweeks. In order to secure the catheter in position at the insertionsite, a health care provider often secures the catheter to the patientusing tape. That is, the health care provider commonly places longpieces of tape across a section of the catheter near the insertion sitein a crisscross pattern to secure the catheter to the patient's skin.This securement inhibits movement of the catheter relative to theinsertion site, as well as prevents the catheter from snagging on thebed rail or other objects.

[0007] Tape, however, often collects dirt and other contaminates. Normalprotocol therefore requires periodic (e.g., daily) tape changes toinhibit bacteria and germ growth at the securement site. Frequent tapechanges, however, create the problem of excoriation of the patient'sskin. Additionally, valuable time is spent applying and reapplying thetape. Further, because many health care providers find the tapingprocedure difficult and cumbersome when wearing latex gloves, they oftenremove their gloves when taping. Not only does this further lengthen thetaping procedure, but it also subjects the health care provider topossible infection. Moreover, even if health care providers remaingloved, contact between the adhesive surface of the tape and the latexgloves causes micro-holes in the gloves, which subjects the health careprovider to possible infection.

[0008] As an alternative to tape securement, some catheters include anintegrated or a movable flexible claim with winged extensions. Theseextensions are sutured to the patient's skin in order to secure thecatheter in position at the insertion site. In other applications, theflexible claim is covered by a rigid box claim, which receives thecatheter/clamp combination in a friction-fit manner. The rigid box clampand the flexible clamp have lateral, aligned holes in them, which allowthe combination to be sutured to the patient's skin. Although thistechnique securely attaches the catheter to the patient, it obviously ispainful and uncomfortable for the patient. This prior retentionprocedure is also time consuming and inconvenient, poses the risk ofneedle-stick to the health care provider, and risks suture-siteinfection to the patient.

[0009] In addition, suture material tends to exhibit poor gripping onmedical tubes and can cut through the winged extension of the flexibleclamp, if a rigid clamp is not used. The use of a rigid clamp, however,complicates the securement procedure by adding yet another componentthat can be dropped on the floor and become unsterile. In addition, thesutured securement of the flexible clamp or the flexible/rigid clampassembly, does not permit easy release of the catheter from the patientfor dressing changes and insertion site cleansing.

SUMMARY OF THE INVENTION

[0010] An aspect of the present invention involves a simply-structuredanchoring system that secures an elongated medical article (e.g., acatheter) in a fixed position relative to an insertion site and resiststugs on the medical article, while facilitating intentional release ofthe medical article from the anchoring system for dressing changes orother servicing. Tools, such as hemostats or surgical clamp, need not beused to release the medical article from the anchoring system.

[0011] In one mode, the anchoring system comprises an anchoring padhaving a first surface and a second surface. The second surface includesan adhesive layer that covers at least a portion of the second surface.A retainer is mounted on the first surface of the anchor pad forreceiving a portion of the medical article. The retainer includes a basethat is attached to the first surface and at least one post that extendsfrom the base. The post has a securing portion, which is arranged towardan outer end of the post. At least one clip is also formed on theretainer. The clip is sized and configured to engage at least a portionof the medical article.

[0012] Another aspect of the present invention involves an anchoringsystem for securing an elongated medical article to a patient. Themedical article includes at least one aperture. The anchoring systemcomprises an anchor pad and a retainer mounted to the anchor pad. Theretainer includes a first retention member that is positioned generallyupright relative to the anchor pad. The first retention member isconfigured to be inserted through the corresponding aperture of themedical article. The retainer also includes a second retention memberthat is coupled to an anchor pad. At least a portion of the secondretention member is positioned to lie generally normal to the firstretention member, and is spaced from the anchor pad by a distance sodimensioned to permit at least a section of the elongated medicalarticle to be placed between the portion of the second retention memberand the anchor pad.

[0013] In accordance with another aspect of the present invention, amethod of securing a medical article to the body of a patient, whereinthe medical article includes an elongated body with pliable wings thatextend out from the body, with each wing including at least one suturehole, is provided. The method involves providing a retainer that has atleast first and second posts, which are spaced apart. A clip of theretainer is positioned to the side of the post. The first post isinserted into one of the suture holes of the pliable wings of themedical article. The pliable wings are stretched so as to position thatother suture hole over to the second post. The stretched wing is thenhooked over the second post so as to insert the second post into thecorresponding suture hole. A section of the elongated body is insertedinto the clip and positioned therein so as to inhibit the elongated bodyfrom disengaging from the clip. In the preferred mode, the retainer isadhered to the body of the patient.

[0014] Further aspects, features and advantages of the present inventionwill become apparent from the detailed description of the preferredembodiment that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The above mentioned and other features of the invention will nowbe described with reference to the drawings of preferred embodiments ofthe present anchoring system. The illustrated embodiments of theanchoring system are intended to illustrate, but not to limit theinvention. The drawings contain the following figures:

[0016]FIG. 1 is a perspective view of an anchoring system in accordancewith a preferred embodiment of the present invention and illustrates anexemplary catheter positioned above the anchoring system;

[0017]FIG. 2a is a perspective view of a retainer of the anchoringsystem of FIG. 1;

[0018]FIG. 2b is a perspective view of another embodiment of a retainerthat can be used with an anchoring system similar to that of FIG. 1;

[0019]FIG. 3a is a front elevation view of the retainer of FIG. 2a;

[0020]FIG. 3b is a front elevation view of the retainer of FIG. 2b;

[0021]FIG. 4a is a side elevation view of the retainer of FIG. 3a;

[0022]FIG. 4b is a side elevation view of the retainer of FIG. 3b;

[0023]FIG. 5 is a bottom plan view of the anchor pad of FIG. 1;

[0024]FIG. 6 is a top plan view of the anchoring system of FIG. 1 with acatheter fitting positioned above the retainer;

[0025]FIG. 7 is a perspective view of the anchoring system of FIG. 1with the catheter fitting partially engaged with the retainer; and

[0026]FIG. 8 is a perspective view of the anchoring system of FIG. 1with the catheter fitting fully engaged with the retainer; and

[0027]FIG. 9 is a perspective view of an anchoring system in accordancewith another preferred embodiment of the present invention andillustrates an exemplary catheter positioned above the anchoring system;

[0028]FIG. 10a is a perspective view of a retainer of the anchoringsystem of FIG. 9; and

[0029]FIG. 10b is a perspective view of another embodiment of a retainerthat can be used with an anchoring system similar to that of FIG. 9.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0030] The present embodiment of the anchoring system for a medicalarticle is disclosed in the context of an exemplary midline catheter.The principles of the present invention, however, are not limited tomidline catheters. Instead, it will be understood by one of skill inthis art, in light of the present disclosure, that the anchoring systemand retainer disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes and electrical wires.For example, but without limitation, the retainer disclosed herein canalso be configured to receive and secure central venous catheters,peripheral catheters, peripherally inserted central catheters,hemodialysis catheters, surgical drainage tubes, feeding tubes, chesttubes, nasogastric tubes, scopes, as well as electrical wires or cablesconnected to external or implanted electronic devices or sensors,provided that these device include either an integrated or movablefitting (e.g., a winged fitting) with one or more securement apertures.One skilled in the art may also find additional applications for thedevices and systems disclosed herein. Thus, the illustration anddescription of the anchoring system in connection with a midlinecatheter is merely exemplary of one possible application of theanchoring system. The catheter in the illustrated embodiment includes atleast a pliable or deformable winged fitting, being formed of siliconeor latex. An exemplary midline catheter, in which both the catheter bodyand the winged fitting are formed of silicone, is available commerciallyfrom Becton, Dickinson and Company of Sandy, Utah.

[0031] Each of the embodiments described herein employ some basicconcepts characteristic of the anchoring system, namely releasableengagement of the medical article to a patient. The releasableengagement is achieved by cooperation among post, clip and catheterfitting elements. This cooperation allows the catheter to bedisconnected from the anchoring system, and from the patient, for any ofa variety of known purposes. For instance, the health care provider maywant to remove the catheter from the anchoring system to easedisconnection of the catheter from the insertion point or to clean thepatient. The disengagement of the catheter from the anchoring system,however, can be accomplished without removing the anchoring system fromthe patient. In addition, the disengagement can be accomplished withoutdestroying the anchoring system and without the use of tools, such as,for example, a hemostat or surgical clamp.

[0032] Each of the embodiments described herein also inhibit axial androtational movement of the catheter with respect to the anchoringsystem. Axial movement is generally inhibited by the holding effectprovided by the posts, which cooperate with holes in the winged catheterfitting. Rotational movement is generally inhibited by the holdingeffect provided by the clip, which cooperates with the post to resistmovement of the catheter which could otherwise cause the catheterfitting to rock, roll, slip or slide from engagement with the posts.

[0033] To assist in the description of these components of the anchoringsystem 10, the following coordinate terms are used. A “longitudinalaxis” is generally parallel to the section of the catheter 12 retainedby the anchoring system 10. A “lateral axis” is normal to thelongitudinal axis and is generally parallel to the plane of the anchorpad 56. A “transverse axis” extends normal to both the longitudinal andlateral axes. In addition, as used herein, “the longitudinal direction”refers to a direction substantially parallel to the longitudinal axis;“the lateral direction” refers to a direction substantially parallel tothe lateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. Also, the terms“proximal” and “distal”, which are used to describe the presentanchoring system 10, are used consistently with the description of theexemplary application. Thus, proximal and distal are used in referenceto the center of the patient's body. A detailed description of theanchoring system 10, and its associated method of use, now follows.

[0034] With reference now to FIGS. 1 and 2, an anchoring system 10 isillustrated and constructed in accordance with preferred embodiments ofthe present invention. The system comprises a retainer 20 and an anchorpad 56. The anchor pad 56 secures the retainer 20 to a patient's skin.The anchor pad 56 has a lower adhesive surface 58 which adheres to theskin of a patient and an upper surface 62 which supports and secures theretainer 20.

[0035] The retainer 20 is sized and configured to accept and retain asection of a catheter 12 (FIGS. 6-8) within the anchoring system 10. Theretainer desirably includes at least first and second retention members.The first retention member is positioned generally upright relative tothe anchor pad 56, and is configured to inserted through thecorresponding aperture 74 (e.g., suture hole) of the catheter fitting14. The first retention member is configured to engage a portion of thecatheter fitting 14 about the aperture 74 so as to inhibit unintentionaldisengagement of the catheter 12 from the first retention member. Thesecond retention member is coupled to the anchor pad 56. At least aportion of the second retention member is positioned to lie generallynormal to the first retention member and is spaced from the anchor pad56 by a sufficient distance to permit at least a section of the catheter12 to be placed between the portion of the second retention member andthe anchor pad 56. The second retention member also is configured toinhibit the received section of the catheter 12 from pulling out ofengagement with the second retention member.

[0036] In the illustrated embodiment, the first retention memberdesirably comprises a post 30 and the second retention member desirablycomprises a clip 48. More preferably, the retainer 20 includes a pair ofposts 30 and a clip 48, which is positioned to the side of the posts 30;however, the retainer 20 can include any combination of posts and clipsin order to suit a particular application, as those skilled in the artwill appreciate. For instance, the retainer 20 can include a single post30 positioned between a pair of clips 48 on the retainer. The posts 30are sized and configured to releasably accept holes 74 formed in thecatheter 12 or a winged catheter fitting 14. The clip 48 is sized andconfigured to releasably accept a portion of the catheter 12.

[0037] With reference to FIG. 2a, the retainer 20 includes a rigidstructure principally formed by a base 22. In the illustratedembodiment, the base 22 is integrally formed with the posts 30 and theclip 48 to comprise a unitary retainer 20. This can be accomplished inany of a variety of ways well known to those skilled in the art. Forinstance, the entire retainer 20 can be injection molded in order toreduce fabrication costs.

[0038] Additionally, as will be apparent from the below description,several features of the retainer 20 (e.g., a clip, and to some extentthe post(s) and the retainer itself) desirably are flexible. Suitablerigid but flexible materials include, for example, but withoutlimitation, plastics, polymers or composites such as polypropylene,polyethylene, polycarbonate, polyvinylchloride, acrylonitrile butadienestyrene, nylon, olefin, acrylic, polyester, as well as moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The illustrated retainer 20 preferably is formed by injectionmolding using a plastic or polymer material. However, other materialscan be utilized, and the retainer 20 can comprise a non-unitary base,posts and/or clip.

[0039] As seen in FIG. 2a, the base 22 comprises an elongated bodyformed substantially along a plane in the longitudinal (X-X) and lateral(Y-Y) directions. The base 22 has a distal end 24 and a proximal end 25.The base 22 can be configured in a wide variety of shapes, such assquare, circular, triangular, curvilinear or the like in order to suit aparticular application. For example, the base 22 may be configuredsimilar to the shape of the anchor pad 56. The illustrated embodimentshows a generally oval base including first and second lateral sides 26,28.

[0040] The longitudinal dimension of the base 22 desirably issufficiently long to provide stability to the catheter 12 along itslength. That is, the longitudinal length of the retained catheter 12portion is sufficient to inhibit rocking of the catheter 12 relative tothe retainer 20 (i.e., to prevent the retainer 20 from acting as afulcrum for the catheter 12). This desirably is also true for thelateral dimension of the retainer 20. In addition, the lateral dimensionof the base 22 desirably allows the health care provider to easily andnaturally grip the retainer 20, as well as provides space on which tolocate one or more posts and one or more clips.

[0041] With reference now to FIGS. 2a, 3 a and 4 a, one or more posts 30extend from the base 22. The illustrated embodiment includes two posts30 that extend substantially upright relative to the base 22. However,the base 22 can also include additional posts 30 to suit a specificapplication. For example, where the retainer 20 is designated to securea relatively large catheter 12 or catheter fitting 14, the base 22 caninclude four posts arranged at the corners of a rectangle, for greaterstability. Also, three posts can be used to firmly anchor a Y-sitefitting.

[0042] Each post 20 includes a shank or shaft 32, attached to andextending from the base 22. The shaft 32 can have a variety of lengthsand a variety of distances between them, depending upon the particularapplication and the particular fitting 14 with which they are tointeract to mount the catheter 12. For anchoring catheters and medicaltubing, each shaft 32 desirably has a length of about 2 mm to 20 mm, andmore particularly a length of about 4 mm; however, longer or shorterlengths also are possible. The shafts 32 are laterally spaced at leastwide enough to accommodate the catheter to be anchored, and in theillustrated embodiments, the shafts 32 are spaced to accommodate thefitting 14 which secures the catheter 12. Desirably, the shafts 32 arespaced apart by a distance slightly greater than the distance betweenthe corresponding suture holes 74 on the retainer 20. In manyapplication, the distance between the posts 30 will be between 5 mm and40 mm, and more particularly generally equal about 20 mm. The shaft 32of each post 30 has a diameter sufficient to perform its structuralfunction, as described in more detail below, and depends upon thematerial chosen for the base 22 and posts 30. The illustrated posts 30comprise a plastic or polymer material, with a diameter between 0.5 mmand 5 mm and particularly about 2 mm.

[0043] It is contemplated that the shaft 32 may be formed in any of avariety of elongated shapes in addition to the cylindrical shape shownin the illustrated embodiments, such as square, triangular and the liketo suit a particular application. As described in greater detail below,the elongated shape of the shaft 32 preferably generally matches theshape of the holes 74 in the catheter fitting 14.

[0044] The shaft 32 has a securing portion which inhibits migration ofthe catheter 12 and catheter fitting 14. The securing portion maycomprise one or more elements described below.

[0045] One element that the securing portion may comprise includes aprotrusion that extends radially from the shaft 32. As shown in FIGS.2a, 3 a and 4 a, the protrusion comprises an enlarged tip or head 34 atthe end distal from the base 22. At least a portion of the circumferenceof the head 34 is larger than the circumference of the shaft 32,desirably having a maximum circumference of 1.1 to 3 times thecircumference of the shaft 32. FIG. 2a shows the head 34 having agenerally hemispherical shape with a smooth surface and a maximumcircumference at an overhanging lower surface or underside 36. It willbe understood, however, that the head 34 can take a variety of othershapes, with or without an underside 36, such as for example, solid orhollow conicals, arrowheads, barbs, spheres, mushroom heads, and othertypes of radially projecting structures. A relatively blunt end 37 ofthe head 34 is preferred to avoid snagging on materials such as a healthcare provider's latex gloves or sheets on the patient's bed.

[0046] As seen in FIGS. 2a, 3 a and 4 a, the underside 36 is generallyplanar. However, the underside 36 may be curved to form a recess 38 inwhich a portion of the catheter fitting 14 may be retained. Theunderside 36 may also have a surface which is roughened or whichincorporates ridges or other snagging devices (not shown) to furtherassist in retaining the catheter fitting 14. However, the underside 36may also be smooth, for less expensive fabrication costs.

[0047] Another element that the securing portion may comprise includes ahook 40. As shown in FIGS. 2b, 3 b and 4 b, the hook 40 has a radialportion 42 which extends outwardly from the shaft 32. Advantageously,the hook 40 has a curved portion 44 distal the shaft 32 and positionedtoward a distal end of the radial portion 44. The curved portion 42 issized and configured to accept a hole in the catheter fitting.Desirably, the curved portion 42 has a chamfer or taper 46 along thedistal circumference to allow a medical attendant to easily fit theholes 74 in the catheter fitting 14 around the hook 40.

[0048] With reference now to FIGS. 1, 2a and 3 a in general, the clip 48is formed on the base 22. The illustrated embodiments show one clip 48extending from the base 22. However, the base 22 can also includeadditional clips to suit a specific application, as noted above. Forexample, where the retainer 20 is designated to secure a relativelylarge catheter, the base can include two clips arranged on opposing endsof the catheter, for greater stability. Also, three clips can be used tofirmly anchor a Y-site catheter.

[0049] The clip 48 is sized and shaped to readily accept a portion ofthe catheter 12 while not easily disengaging the accepted portion of thecatheter 12. Advantageously, the clip 48 inhibits transverse movement ofat least a portion of the catheter 12. Transverse movement of thecatheter 12 is inhibited by contact with the clip 48, which is ofsufficiently rigid construction and secured to the base 22 to act as astop against advancement of the catheter 12 in the transverse direction.Inhibition of transverse movement of the catheter is advantageousbecause this movement can translate into movement of the catheter 12 atthe engagement site between the catheter 12 (or catheter fitting 14) andpost 30. This movement, in turn, can cause the catheter fitting 14 toroll or slip off the posts 30 and slide from engagement with the posts30.

[0050] The clip 48 can be configured in a variety of ways to achieve itspurpose. FIG. 2a illustrates a substantially C-shaped clip within whicha portion of the catheter 12 is captured. FIG. 2c illustrates a pair ofa semi-rigid, inverted L-shaped members that are closely spaced apart toreleasably accept a catheter 12 that is sized greater than the spacingbetween the L-shaped members. As will be understood by one skilled inthe art, a variety of other clip configurations, such as a singleL-shaped clip, can be used to achieve the purpose of the clip.

[0051] The clip 48 may also include a hook portion 52 as describedabove, or a variety of other snagging, hooking and inhibiting devices asdescribed above. The clip 48 can have a variety of sizes depending uponthe particular application and the particular catheter 12 with which itis used.

[0052] In the illustrated embodiment, the clip 48 is arranged along alongitudinally extending line that substantially bisects a laterallyextending line that extends between the two posts 30. An area 54 isformed on the retainer between the first and second sides and desirablylaterally between the posts 30. The area 54 is sized and shaped so as toaccept and retain a portion of a catheter 12 in a close fit mannerbetween the posts 30 and the clip 48.

[0053]FIG. 1 illustrates an anchor pad 56 which desirably comprises alaminate structure with an upper foam layer (e.g., closed-cellpolyethylene foam), and a lower adhesive layer. The lower adhesive layerconstitutes the lower surface 58 of the anchor pad 56. The lower surface58 desirably is a medical-grade adhesive and can be either diaphoreticor nondiaphoretic, depending upon the particular application. Such foamwith an adhesive layer is available commercially from New Dimensions inMedicine of Columbus, Ohio. The illustrated embodiment shows the anchorpad 56 having suture holes 60 in addition to the adhesive layer tofurther secure the anchor pad 56 to the patient's skin. It will beunderstood, however, that the anchor pad 56 need not include sutureholes 60 to secure the anchor pad 56 to the patient's skin.

[0054] A surface of the upper foam layer constitutes an upper surface 62of the anchor pad 56. The upper surface 62 desirably is roughened bycorona-treating the foam with a low electric charge. The roughened orporous upper surface 62 improves the quality of the adhesive joint(which is described below) between the base 22 and the anchor pad 56. Inthe alternative, the flexible anchor pad 56 can comprise a medical-gradeadhesive lower layer, an inner foam layer and an upper paper or otherwoven or nonwoven cloth layer.

[0055] In the illustrated embodiment, the anchor pad 56 also desirablyincludes a pair of opposing crescent sections 64, 66 with a recesstoward the proximal end 24 of the anchor pad 56 proximate to the clip48. As a result, the lateral sides of the anchor pad 56 have morecontact area which provides greater stability and adhesion to apatient's skin.

[0056]FIG. 5 shows a removable paper or plastic release liner 68 whichdesirably covers the adhesive lower surface 58 before use. The liner 68preferably resists tearing and desirably is divided into a plurality ofpieces to ease attachment of the pad to a patient's skin. In theillustrated embodiment, the liner 68 is split along a center line 70 ofthe flexible anchor pad 56 in order to expose only half of the adhesivelower surface 58 at one time.

[0057] The liner 68 length extends beyond the center line 70 of theanchor pad 56 and is folded over, or back onto the liner 68. This foldedover portion defines a pull tab 71 to facilitate removal of the liner 68from the adhesive lower surface 58. A medical attendant uses the pulltab 71 by grasping and pulling on it so that the liner 68 is separatedfrom the lower surface 58. The pull tab 71 overcomes any requirementthat the medical attendant pick at a corner edge or other segment of theliner 68 in order to separate the liner 68 from the adhesive layer. Thepull tab 71 of course can be designed in a variety of configurations.For example, the pull tab 71 need not be located along the center line70 of the anchor pad 56; rather, the pull tab 71 may be located alongany line or portion of the anchor pad 56 in order to ease theapplication of the anchor pad 56 onto the patient's skin at a specificsite. For example, an area of a patient's skin with an abrupt bend, suchas at a joint, may require that the pull tab 71 be aligned toward one ofthe lateral ends of the anchor pad 56 rather than along the center line70.

[0058] The base 22 of the retainer 20 is attached to the upper surface62 of the anchor pad 56. The base 22 desirably is secured to the uppersurface 62 by a solvent bond adhesive, such as cyanoacrylate or otherbonding material. One such adhesive is available commercially as PartNo. 4693 from the Minnesota Mining and Manufacturing Company (3M).

[0059] When the anchoring system 10 is assembled as described above, thearea 54 formed on the base 22 defines a receiving space 72. Thereceiving space 72 is capable of accepting a portion or length of thecatheter 12. Although the receiving space 72 may take the form ofvarious shapes depending upon its application (i.e., depending upon ashape of the retained portion of the medical article for which theretainer 20 is designed to be used), the receiving space 72 does have asufficient length in the longitudinal direction to stabilize thecatheter 12, rather than act as a fulcrum for the catheter 12, asmentioned above. That is, the longitudinal spacing between the posts 30and the clip 48 on the retainer 20 is sized so as to receive sufficientlength of the catheter 12 to inhibit movement of the catheter 12 in thelateral, longitudinal and transverse direction (i.e., to inhibit yaw,pitch and axial movement of the catheter 12), without kinking thecatheter 12.

[0060] When the catheter fitting 14 is placed onto the posts 30 via theholes 74 and pressed onto the receiving space 72, a section of thecatheter 12 is captured within the retainer 20. Desirably, the catheterfitting 14 is constructed of material that is more elastic than theretainer 20 and the distance between the posts 30 is slightly largerthan the distance between the holes 74 in the catheter fitting 14. Bythis design, when the catheter fitting 14 is stretched to allow theposts 30 to accept the catheter fitting holes 74, a tensile force isapplied to the catheter fitting 14 and a tight-fit relationship betweenthe posts 30 and catheter fitting 14 exists to inhibit axial androtational movement of the catheter 12. Rotational movement of thecatheter 12 is further inhibited by the clip 30, as described above.

[0061] In operation and as illustrated in FIGS. 6-8, a medical attendantmay secure a catheter 12 (or other medical article) to a patient usingthe above-described anchoring system (or a readily apparent modificationthereof). The medical attendant first transversely aligns the holes 74in the catheter fitting 14 over the posts 30. The catheter 12 may thenbe placed into the receiving space 72 formed between the lateral sidesof the base 22 by engaging the holes 74 in the catheter fitting 14around the post 30. This is done by first inserting a first post intoone of the suture holes 74, as seen in FIG. 7, and then stretching thefitting 14 so as to align the other suture hole 74 over the second post30. The fitting 14 is then slipped over the second post 30 by insertingthe post 30 into the hole 74. In doing so, the catheter fitting 14 ishooked under the lower surface 36 of the post 30. The interactionbetween the under surface 36 of the posts 30 and the portions of thecatheter fitting 14 about the suture holes 74 inhibits the catheterfitting from pulling off the posts 30 in a transverse direction. And thegeneral interaction between the posts 30 and the fitting 14 inhibitssignificant (i.e., meaningful) longitudinal and lateral movement of thecatheter 12 relative to the retainer 20.

[0062] As seen in FIG. 8, a distal section of the catheter 12 isinserted into the clamp 48 by positioning the catheter 12 next to anopening in the clip 48 and pulling the catheter 12 into the clip. Thedeformable nature of the catheter 12, and/or the deflectable nature ofthe clip 48 permits the catheter section to be inserted into a spacebetween at least a section of the clip 48 and the base 22. Importantly,a portion of the clip 48 extends generally parallel to the base 22 andgenerally normal to the posts 30. This section of the clip 48 preventsthe distal portion of the catheter 12, which is unsecured behind clip48, from applying a transverse force on the catheter fitting 14 whenpulled transversely away from the retainer. As a result of this design,greater transverse force can be applied to the catheter before itdisengages from the retainer, in comparison to a design that does notinclude a clip 48.

[0063] If the catheter 12 is pulled in an axial or rotational direction,interaction between the posts 30, clip 48 and catheter fitting 14 alsoprevents the catheter 12 from appreciable movement. The retainer 20 thusinhibits axial or rotational movement of the catheter 12 relative to theretainer 20.

[0064] Importantly, the posts 30 and clip 48 do not crimp or kink thecatheter 12 body when it is inserted within the receiving space 72.Moreover, although the post 30 and clip 48 bear against the catheter,their limited pressure does not significantly occlude the correspondingcatheter 12 lumen(s). Although FIG. 8 illustrates a space between thesecuring portions 34 of the posts 30 and the catheter fitting 14, theshafts 32 of the posts 30 can be sized for a particular catheter fitting14 so as to reduce the amount of transverse play of the catheter fittingwithin the anchoring system when secured.

[0065]FIGS. 9 and 10 illustrate an anchoring system configured inaccordance with another embodiment of the present invention. Like theanchoring system of the previous embodiment, this anchoring systemincludes a retainer with at least one retention member and an anchorpad. However, the particular configuration of these elements differsslightly. Also, the particular configuration of the medical article thatconnects to the anchoring system differs. Thus, for consistency, likenumbers with an “a” suffix have been used to indicate like parts of theanchoring system of FIGS. 1-8. The above description of the likecomponents thus should be understood as applying equally to the presentembodiment of the anchoring system 10 a, unless otherwise stated.

[0066] With reference to FIG. 9, the illustrated catheter fitting 14 ais constructed entirely from a silicon material for pliability purposes,which allows the pair holes 74 a in the laterally extending wing portion13 a of the fitting 14 a to be enlarged during connection ordisconnection operations. The catheter fitting 14 a also has an elongatebody with an inner lumen that houses the catheter 12 a and can beattached to a plastic connecting piece 10. The exemplary midlinecatheter 12 a is available commercially from Becton, Dickinson andCompany of Sandy, Utah as First Mid-Cath™.

[0067] Like the previous embodiment, the retainer 20 a is constructed,sized and configured to receive a portion of the catheter fitting 14 aand to provide space on which to locate at least one retention member.

[0068] With reference to FIG. 10, the first retention member desirablycomprises two laterally spaced posts 30 a, although one, three or moreposts can be used. Each post 30 a includes a shank or shaft 32 aattached to and extending generally upright from the base 22 a. Eachshaft 32 a has a length of about 2 mm to 20 mm and desirably about 4 mm,and is laterally spaced apart a distance of 5 mm to 40 mm from the othershaft 32 a, and desirably about 20 mm. The shaft 32 a of each post 30 ahas a diameter sufficient to perform its structural function, with theillustrated shafts 32 a having a diameter between 0.5 mm and 5 mm anddesirably about 2 mm.

[0069] The shaft 32 a may include a securing portion to inhibitmigration of the catheter 12 a and catheter fitting 14 a relative to theshaft 32 a. If used, the securing portion may comprise one or moreelements previously described or described below. Alternatively, theshaft 32 a may forgo use of a securing portion to assist in connectingor disconnecting operations, as explained below.

[0070] One element that the securing portion may comprise is aprotrusion that extends radially outwardly from the end of the shaft 32a distal the base 22 a. As best shown in FIG. 10A, the protrusioncomprises a generally smooth angular enlarged tip or head 34 a with anunderside 36 a that radially extends around the entire diameter of theshaft 32 a. It will be understood, however, that the head 34 a can takea variety of other shapes, with or without an underside 36 a or portionthereof, such as for example, solid or hollow conicals, arrowheads,barbs, spheres, mushroom heads, hemispheres and other types of radiallyprojecting structures. A relatively blunt end 37 a of the head 34 a ispreferred to avoid snagging on materials such as a health careprovider's latex gloves or sheets on the patient's bed. Alternatively, arelatively rounded end 100 of the head 34 a is preferred to assist infitting the holes 74 a over the head 34 a. At least one of the heads 34a may optionally include an angled extended portion 102 that faces awayfrom the other post 30 a. The angled portion 102 is sized and configuredto accept the hole 74 a of the catheter fitting 14 a and desirably has achamfer or taper 46 a along the outer end to more easily fit the hole 74a of the catheter fitting 14 a around the angled portion 102. Once thehole 74 a is fitted around the angled portion 102, the hole 74 a can beadvanced/stretched around the head 34 a and then onto the shaft 32 a.

[0071] Another element that the securing portion may comprise is also aprotrusion that extends radially outwardly from the end of the shaft 32a distal the base 22 a. As shown in FIG. 10B, the protrusion comprises agenerally smooth rounded enlarged tip or bulb 104 not having anunderside. However, an underside that radially extends around the entirelength of the shaft 32 a or a portion thereof could be used. Arelatively blunt end 106 of the bulb 104 is preferred to avoid snaggingon materials such as a health care provider's latex gloves or sheets onthe patient's bed. Alternatively, a relatively rounded end 108 of thebulb 104 is preferred to assist in fitting the holes 74 a around thebulb 104. The bulb 104 may optionally include a curved extended portion110 that faces away from the other post 30 a. The curved portion 110 issized and configured to accept the hole 74 a in the catheter fitting 14a and desirably has a chamfer or taper 46 a along the free end to moreeasily fit the hole 74 a in the catheter fitting 14 a around the curvedportion 110. Once the hole 74 a is fitted around the curved portion 110,the hole 74 a can be advanced around the bulb 104 and then onto theshaft 32 a.

[0072] As noted above, both shafts 32 a need not include a securingportion. If a securing portion is not used, the end of the shaft 32 adistal the base 22 a desirably has a smooth slightly rounded surface.This configuration assists in fitting the holes 74 a in the catheterfitting 14 a onto the shaft 32 a. This configuration (not shown)provides for more easy engagement of the hole 74 a with the shaft 32 a(i.e. the hole 74 a is not required to further enlarge to fit over thehead 34 a or bulb 104); however, the use of the securing portion 34 a onboth shafts 32 a increases the security of the catheter fitting 14 a onthe retainer 20 a.

[0073] With reference again to FIG. 10, the second securing membercomprises a clip 48 a that extends from the base 22 a. Like the previousembodiment, the clip 48 a is sized and shaped to readily accept aportion of the catheter fitting 14 a or a section of the catheter 12 awhile not easily disengaging the accepted portion of the catheterfitting 14 a or catheter 12 a. Advantageously, the clip 48 a alsoinhibits transverse movement of at least a portion of the catheterfitting 14 a.

[0074] The clip 48 a can be configured in a variety of ways to achieveits purpose. For example, FIG. 10A shows the clip 48 a being generally Cshaped and configured generally similar to the clip of FIG. 2A. However,the present embodiment of the clip 48 a has a larger, more defined hookportion 52 a that extends toward the base 22 a to narrow or partiallyocclude the entranceway 112 into the clip interior 114. The narrowedentranceway 112 requires the medical attendant to flatten or otherwisecontort a portion of the catheter fitting 14 a when passing it throughthe entranceway 112 and into the clip interior 114. Once a portion ofthe catheter fitting 14 a is positioned within the clip interior 114,the narrowed entranceway 112 requires that a portion of the catheterfitting 14 a be flattened or otherwise contorted to dislodge thecatheter fitting 14 a from the clip interior 114. This arrangementinhibits accidental dislodgment of the catheter fitting 14 a from theclip interior 114. In particular, the illustrated narrowed entranceway112 has a transverse height that is less than three quarters of thetransverse height of the catheter fitting 14 a and desirably less than{fraction (1/2)} the transverse height of the catheter 12 a and moredesirably about one-half of the transverse height of the catheterfitting 14 a. Stated alternatively, for use in connection with theillustrated catheter fitting 14 a, the narrowed entranceway 112 has atransverse height of about 1 mm to 5 mm and desirably about 3 mm.

[0075] For another example, FIG. 10B shows the clip 48 a being agenerally inversely L-shaped and configured generally similar to theclip of FIG. 2B. However, the present embodiment of the clip 48 a doesnot include any hook portion at all. Thus, the entranceway 112 to theclip interior 114 is not narrowed or partially occluded, whichfacilitates insertion or removal of the catheter fitting 14 a into theclip interior 114. In particular, the clip 48 a has a transverse heightthan is the same or slightly greater than the transverse height of thecatheter fitting 14 a, or, for use with the illustrated catheter fitting14 a, about 3 to 10 mm and desirably about 6 mm.

[0076]FIG. 9 illustrates an anchor pad 56 a including a laminatestructure with an upper foam layer 62 a, a lower adhesive layer 58 a andsuture holes 60 a formed through the layers 58 a, 62 a that isconstructed similar to the anchor pad of FIG. 1. Although the particularconfiguration of the anchor pad 56 a is generally similar to the anchorpad of FIG. 1 (i.e. includes a pair of opposing crescent sections 64 a,66 a with a recess area 116 toward the clip 48 a end of the pad 56 a),the particular configuration of the anchor pad 56 a has a less severepair of opposing crescent sections 64 a, 66 a and a less defined recessarea 116. This configuration provides sufficient contact area forgreater stability and adhesion to a patient's skin. Also, the anchor pad56 a is not sized and configured generally similar to the size and shapeof the release liner 68 a. That is, the release liner 68 a covers theadhesive lower surface 58 a of the anchor pad 56 a as well as the recessarea 116.

[0077]FIG. 10A illustrates a particularly advantageous embodiment of theanchoring system 10 a. The anchoring system 10 a utilizes a firstretention member that comprises a pair of posts 30 a wherein one posthas a securing portion including a head 34 a with a relatively blunt end37 a and a tapered angled extended portion 102, and the other post has asecuring portion including a head 34 a with a relatively rounded end 100and no angled extended portion. This combination allows the medicalattendant to easily connect the catheter fitting 14 a to the retainer 20a by first fitting a hole 74 a in the catheter fitting 14 a through theangled extended portion 102 of the post 30 a, then over the head 34 a,and then onto the shaft 32 a. The other hole 74 a in the catheterfitting 14 a can then be fit onto the other post 30 a (which does nothave the angled extended portion 102). The other hole 74 a can be moreeasily fit onto the other shaft 32 a via the rounded end 100 than if theother shaft 32 a included a blunt end 37 a or further included an angledextended portion 102 that faced away from the secured hole 74 a. Thus,by this synergistic configuration, the holes 74 a are easily fit ontoboth posts 30 a and both posts 30 a have a securing portion to inhibitcatheter migration. The illustrated anchoring system also includes asecond retention member embodied as a clip 48 a with a hook portion 52 athat transversely narrows the entranceway 112 to the clip interior 114to about {fraction (1/2)} the transverse height of the catheter 12 a.

[0078]FIG. 10B illustrates another particularly advantageous embodimentof the anchoring system 10 a that uses the combination of a firstretention member comprising a pair of posts 30 a wherein one post has asecuring portion including a bulb 104 with a relatively blunt end 106and an curved extended portion 110, and the other post 30 a has asecuring portion including a bulb 104 with a relatively rounded end 108and no curved extended portion. Like the embodiment of FIG. 10A, thiscombination allows the medical attendant to easily connect the catheter12 a to the retainer 20 a by first fitting a hole 74 a in the catheterfitting 14 a through the curved extended portion 110, then over the bulb104, and then onto the shaft 32 a. The other hole 74 a in the catheterfitting 14 a can then be fit onto the other post 30 a (which does nothave a curved extended portion 110). The other hole 74 a can be moreeasily fit onto the other shaft 32 a via the rounded end 108 than if theother shaft 32 a included a blunt end 106 or further included a curvedextended portion 110 that faced away from the secured hole 74 a. Thus,by this synergistic configuration, the holes 74 a are easily fit ontoboth posts 30 a and both posts 30 a have a securing portion to inhibitcatheter migration. The illustrated anchoring system 10 a also includesa second retention member embodied as a clip 48 a without a hook portion52 a so that the transverse height of the entranceway 112 is notnarrowed toward the clip interior 114.

[0079] The present anchoring system thus provides a sterile,tight-gripping, needle and tape-free way to anchor a catheter to apatient. The retainer 20 thus eliminates use of tape, and if priorprotocol required suturing, it also eliminates accidental needle sticks,suture-wound-site infections and scarring. In addition, the retainer 20can be configured to be used with any of a wide variety of catheters 12,fittings 14, tubes, wires, and other medical articles. Patient comfortis also enhanced and application time is decreased with the use of thepresent anchoring system.

[0080] Although this invention has been described in terms of certainpreferred embodiments and suggested possible modifications thereto,other embodiments and modifications apparent to those of ordinary skillin the art are also within the scope of this invention. It is alsounderstood that various aspects of one or several embodiments can beused with another or several embodiments. It is further understood thatnot all of the aspects or elements described in connection with aparticular embodiment need to be utilized in connection with that oranother embodiment. Accordingly, the scope of the invention is intendedto be defined only by the claims which follow.

What is claimed is:
 1. A catheterization system for securing anelongated medical article to a patient, comprising: an anchor pad havinga first surface and a second surface, the second surface including anadhesive layer that covers at least a portion of second surface; aretainer mounted on the first surface of the anchor pad for receiving aportion of the medical article, the retainer having a base attached tothe first surface and at least one post that extends from the base, thepost having a securing portion arranged toward an outer end of the post;and at least one clip formed on the retainer and sized and configured toengage at least a portion of the medical article.
 2. An anchoring systemas in claim 1 , wherein the retainer includes a plurality of posts, andeach of the posts has a shaft attached to and extending from the base,and the securing portion is sized and configured to permit engagementbetween a portion of the medical article and the shaft, and to inhibitunintentional disengagement of the portion of the medical article fromthe shaft once engaged.
 3. An anchoring system as in claim 2 , whereinthe securing portion of each post includes a head, at least a portion ofthe head having a peripheral size larger than a peripheral size of thecorresponding shaft.
 4. An anchoring system as in claim 3 , wherein acircumference of the head is larger than a circumference of the shaft.5. An anchoring system as in claim 2 , wherein the securing portion ofat least one of the posts includes a hook portion.
 6. An anchoringsystem as in claim 5 , wherein the hook portion is spaced from theshaft.
 7. An anchoring system as in claim 2 , wherein at least two postsare spaced apart by sufficient distance to accommodate at least aportion of an elongated medical article between the posts.
 8. Ananchoring system as in claim 7 , wherein the clip is spaced from eachpost.
 9. An anchoring system as in claim 8 , wherein the clip isarranged along a line that substantially bisects a line between the twoposts.
 10. An anchoring system as in claim 1 , wherein the base, postand clips form a unitary structure.
 11. An anchoring system for securingan elongated medical article to a patient, the medical article includingat least one aperture, the anchoring system comprising an anchor pad anda retainer mounted to the anchor pad, the retainer including a firstretention member being positioned generally upright relative to theanchor pad, and being configured to inserted through the correspondingaperture of the medical article, and a second retention member of whichat least a portion is positioned to lie generally normal to the firstretention member being spaced from the anchor pad by a distance sodimensioned to permit at least a section of the elongated medicalarticle to be placed between the portion of the second retention memberand the anchor pad.
 12. An anchoring system as in claim 11 , wherein thefirst retention member includes means for engaging a portion of themedical article about the aperture so as to inhibit unintentionaldisengagement of the medical article from the first retention member.13. An anchoring system as in claim 11 , wherein the second retentionmember includes means for inhibiting the section of the elongatedmedical article, which is received in an interposed position between theportion of the second retention member and the anchor pad, fromdislodging from the interposed position.
 14. An anchoring system as inclaim 11 , wherein the retainer comprises a third retention member thatis positioned generally normal to the second retention member.
 15. Ananchoring system as in claim 14 , wherein the third retention memberlies generally parallel to the first retention member.
 16. An anchoringsystem as in claim 15 , wherein each of the first and third retentionmembers includes a post having a stem and a securing portion.
 17. Ananchoring system as in claim 16 , wherein the securing portion of eachpost includes a hooked section that extends toward the anchor pad, andthe hooked section is spaced from the post.
 18. An anchoring system asin claim 11 , wherein the retainer includes a third retention memberthat is positioned generally parallel to the second retention member.19. An anchoring system as in claim 11 , in combination with anelongated medical article, wherein the aperture is formed is a wingsection on the medical article.
 20. A combination of claim 19 , whereinthe wing section is formed of a deformable material.
 21. A method ofsecuring a medical article to the body of a patient, the medical articleincluding an elongated body with pliable wings extending from the body,each wing including at least one suture hole, the method comprising:providing a retainer having at least first and second posts that arespaced apart and a clip that is positioned to the sides of the posts;inserting the first posts into one of the suture holes; stretching thewings to position the other suture hole over the second post; hookingthe wing over the second post while inserting the second post into thecorresponding suture hole; inserting a section of the elongated bodywithin the clip so as to inhibit the elongated body from disengagingfrom the clip.
 22. A method as in claim 21 , additionally comprisingadhering the retainer to the patient.
 23. An anchoring system forsecuring a catheter to a patient, comprising: an anchor pad having afirst surface and a second surface, a retainer mounted on the firstsurface of the anchor pad for receiving a portion of the catheter, theretainer having a base attached to the first surface and a plurality ofposts that extend from the base; and at least one clip formed on theretainer and sized and configured to engage at least a portion of afitting of the catheter.
 24. An anchoring system as in claim 23 ,wherein the retainer includes two posts, and each of the posts having ashaft attached to and extending from the base, and each of the postsinclude a securing portion that is sized and configured to permitengagement between a portion of the catheter and the shafts and toinhibit unintentional disengagement of the portion of the catheter fromthe shaft once engaged.
 25. An anchoring system as in claim 24 , whereinthe securing portion of each post includes a head, at least a portion ofthe head having a perimeter size larger than a perimeter size of thecorresponding shaft.
 26. An anchoring system as in claim 25 , whereinone of the posts has a head that further comprises a radially extendedportion that faces away from the head of the other post.
 27. Ananchoring system as in claim 26 , wherein the extended portion is angledtoward the retainer base
 28. An anchoring system as in claim 27 ,wherein the extended portion has a taper directed toward an outer end ofthe extended portion.
 29. An anchoring system as in claim 25 , whereinat least one of the posts has a head with a blunt rounded end distal ofthe retainer.
 30. An anchoring system as in claim 25 , wherein at leasta portion of each of the heads has a generally flat underside surface toinhibit unintentional disengagement of the fitting from the post onceengaged.
 31. An anchoring system as in claim 24 , wherein the securingportion of each post includes a bulb, at least a portion of the bulbhaving a perimeter size larger than a perimeter size of thecorresponding shaft.
 32. An anchoring system as in claim 31 , whereinone of the posts has a bulb that further comprises a radially extendedportion that faces away from the bulb of the other post.
 33. Ananchoring system as in claim 32 , wherein the extended portion is curvedtoward the retainer base and has a taper directed toward an outer end ofthe extended portion to form a hook that further assists in engagementbetween the fitting and the post and inhibits unintentionaldisengagement of the fitting from the post once engaged.
 34. Ananchoring system as in claim 23 , wherein the clip has a hook portionthat extends toward the retainer and narrows an entranceway into aninterior of the clip to inhibit unintentional disengagement of thefitting from the clip once engaged.
 35. An anchoring system as in claim34 , wherein the hook portion is so configured to narrow the entrancewayto a transverse height that is less that three-quarters of thetransverse height of the catheter fitting.
 36. An anchoring system as inclaim 35 , wherein the hook portion is so configured to narrow theentranceway to a transverse height that is about one-half of thetransverse height of the catheter fitting.